Potassium B. Braun 0.02 mEq/ml prediluted in glucose 5% solution for infusion

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Potassium B. Braun 0.02 mEq/ml Pre-diluted in Glucose 5% solution for infusion

Potassium chloride and Glucose

Read all of this leaflet carefully before you start using this medicine, because it contains important information for you.

• Keep this leaflet; you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Contents of the leaflet:

1. What Potassium B. Braun 0.02 mEq/ml Pre-diluted in Glucose 5% is and what it is used for
2. What you need to know before using Potassium B. Braun 0.02 mEq/ml Pre-diluted in Glucose 5%
3. How to use Potassium B. Braun 0.02 mEq/ml Pre-diluted in Glucose 5%
4. Possible side effects
5. How to store Potassium B. Braun 0.02 mEq/ml Pre-diluted in Glucose 5%

Contents of the pack and other information

1. What Potassium B. Braun 0.02 mEq/ml Pre-diluted in 5% Glucose is and what it is used for

This medicine contains a solution of potassium chloride and glucose. It is administered through a narrow intravenous catheter (intravenous infusion).

This medicine is used to maintain or restore your potassium levels and to meet your basic energy requirements.

2. What you need to know before using Potassium B. Braun 0.02 mEq/mL in 5% Glucose Premixed Solution

Do not use Potassium B. Braun 0.02 mEq/mL in 5% Glucose Premixed Solution

• if you have abnormally high levels of potassium or chloride in your blood (severe hyperkalemia or hyperchloremia)

• if you have severe kidney disease

• if you have sustained head injuries (within the first 24 hours)

• if you have excess water in your body (hyperhydration)

• if you have elevated blood glucose levels (hyperglycemia) requiring more than 6 units of insulin per hour for control.

Warnings and precautions

Talk to your doctor before using Potassium B. Braun 0.02 mEq/mL in 5% Glucose Premixed Solution.

Your doctor will exercise particular caution when administering this medicine if you have:

• Kidney problems:

You will receive this medicine as a slow intravenous infusion after your doctor has confirmed that your kidneys are functioning properly. If you have kidney problems, your potassium levels, blood parameters, and electrocardiogram (ECG) will be monitored during treatment. Your doctor will ensure that the infusion is stopped if your condition worsens.

• Heart disease:

If you have heart disease, this medicine will be administered with caution.

• Swelling of the lower limbs (edematous states) or fluid in the lungs (pulmonary edema):

If you have any of these conditions, large volumes of this medicine will be administered only with careful monitoring.

• High levels of electrolytes in the blood:

When this medicine is administered, patients who are seriously ill, in pain, experiencing postoperative stress, infections, burns, nervous system, heart, liver or kidney diseases, or patients taking medications with vasopressin-like effects (a hormone regulating body fluid levels), are at special risk of developing abnormally low sodium levels in the blood (acute hyponatremia), which may lead to potentially fatal brain swelling (hyponatremic encephalopathy, cerebral edema).

Women of childbearing age and patients with severe brain disorders, such as infection of the membranes surrounding the brain (meningitis) or brain injury (intracranial hemorrhage, cerebral contusion), are at particular risk of developing severe and potentially fatal cerebral swelling due to abnormally low blood sodium levels.

To prevent excessively low blood sodium levels (hyponatremia), appropriate amounts of sodium may be administered additionally.

• Certain types of diabetes:

This medicine will be administered with caution

• if you have diabetes
• in other conditions where your body does not process sugars normally (e.g., if you are taking other medications; see section "Use of Potassium B. Braun 0.02 mEq/mL in 5% Glucose Premixed Solution with other medicines")

Your blood glucose levels will be monitored.

• Blood transfusion:

This medicine must not be administered simultaneously, or immediately before or after blood transfusion, through the same intravenous line.

• After suffering a stroke:

You should normally not receive this medicine if you have recently had or currently have a stroke, unless your doctor considers it essential for your recovery.

• Excess potassium in the blood:

If you have a condition in which potassium levels are too high in your blood, such as Addison's disease (a specific adrenal gland disorder) or sickle cell anemia (an inherited red blood cell disorder).

Your electrocardiogram (ECG), fluid balance, blood electrolytes, and glucose levels will be checked regularly during treatment.

An adequate supply of vitamins (particularly vitamin B1) will be ensured.

Elderly patients, who are more likely to have heart and kidney problems, will be continuously monitored during treatment, and the dose will be carefully adjusted.

Children

Children are at special risk of developing severe and potentially fatal cerebral swelling due to abnormally low blood sodium levels (hyponatremia).

This medicine will be administered to children with special caution. Your doctor will closely monitor electrolyte levels and fluid balance.

Use of Potassium B. Braun 0.02 mEq/mL in 5% Glucose Premixed Solution with other medicines

Tell your doctor if you are currently using or have recently used any other medicines.

If you are taking digoxin or similar medicines that affect heart function, inform your doctor, as their effects may change. The amount of Potassium B. Braun 0.02 mEq/mL in 5% Glucose Premixed Solution may need to be adjusted, especially toward the end of treatment.

Inform your doctor if you are taking potassium-containing medicines or medicines that may cause high potassium levels, such as:

• Potassium-sparing agents, e.g., spironolactone or triamterene (medicines that increase urine flow)
• ACE inhibitors (medicines for high blood pressure or heart failure)
• AT1-receptor antagonists (medicines for high blood pressure)
• Non-steroidal anti-inflammatory drugs (for acute or chronic pain and inflammation)
• Cyclosporine, tacrolimus (medicines used after organ transplantation)
• Suxamethonium (a medicine used during anesthesia)

Your doctor will exercise special caution if you are receiving/taking medicines that retain potassium, as they may cause heart problems (cardiac arrhythmia). If you are taking certain medicines called corticosteroids, adrenocorticotropic hormone, or loop diuretics, the amount of potassium lost through the kidneys may increase.

Your doctor will administer this solution only with caution if you are taking any of the following medicines that act like vasopressin or enhance vasopressin's effect, thereby increasing the risk of low blood sodium levels (hyponatremia):

• Carbamazepine and oxcarbazepine, used to treat epilepsy
• Clofibrate, used to treat high blood fat levels
• Vincristine and ifosfamide, used as cancer treatments
• Cyclophosphamide, used to treat cancer and autoimmune diseases
• Selective serotonin reuptake inhibitors (SSRIs), used to treat depression
• Antipsychotics, used to treat mental disorders
• Opioid analgesics, used to relieve severe pain
• Non-steroidal anti-inflammatory drugs (NSAIDs), used to relieve mild to moderate pain and treat inflammation
• Chlorpropamide, used to treat diabetes mellitus (high blood sugar after meals)
• Desmopressin, used to treat diabetes insipidus (extreme thirst and continuous production of large volumes of dilute urine)
• Oxytocin, used during childbirth
• Vasopressin and terlipressin, used to treat bleeding esophageal varices (dilated veins in the digestive tract due to liver problems)
• 3,4-methylenedioxy-N-methamphetamine (MDMA, "ecstasy"), an illegal drug
• Diuretics (medicines that increase urine output)

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

This medicine may be used during pregnancy and breastfeeding if your doctor considers it necessary.

Driving and use of machines

Potassium B. Braun 0.02 mEq/mL in 5% Glucose Premixed Solution has no effect on the ability to drive or operate machinery.

3. How to use Potassium B. Braun 0.02 mEq/ml Premixed in 5% Glucose

Follow exactly the administration instructions given by your doctor. If in doubt, consult your doctor again.

Your doctor may monitor your fluid balance, glucose, and electrolyte levels (including sodium) in the blood before and during treatment, especially in patients with increased vasopressin production (a hormone that regulates the body's fluid levels) and in patients taking medications that act like vasopressin, because there is a risk of abnormally low sodium levels in the blood (hyponatremia). See also the sections "Warnings and precautions", "Use with other medicines and Potassium B. Braun 0.02 mEq/ml Premixed in 5% Glucose", and "Possible side effects".

Dosage

Your doctor will determine the amount of medication to be administered, based on your age, weight, and condition, particularly if your heart or kidneys are not functioning properly. While you are receiving this medication, your blood glucose and electrolyte (salts) levels, fluid balance, and electrocardiogram will be routinely monitored. Your doctor will ensure that your urine output is adequate.

The recommended maximum dose for an adult is 40 ml per kg of body weight per day. In cases where more potassium is required, your doctor will consider the use of other doses.

This medicine will be administered for as long as you require salts and fluids via infusion.

Elderly patients

In principle, the same dose as in adults may be used. However, the dose may be adjusted to avoid heart and kidney problems.

Use in children and adolescents

In children and adolescents, your doctor will determine the dose individually; therefore, your child may receive a lower dose.

Method of administration

This medicine will be administered through an intravenous infusion (intravenous drip) into a vein.

If you receive more Potassium B. Braun 0.02 mEq/ml Premixed in 5% Glucose than you should

This is unlikely to occur, as your doctor will determine your daily dose.

Signs of overdose

If you receive too much medication or have kidney problems, your salt, sugar, and water and acid-base balances may be affected. You may also experience tissue fluid accumulation and potassium intoxication.

Blood potassium levels may increase excessively. Signs of this disorder may include:

• Low blood pressure (hypotension)
• Irregular heartbeat or cessation of heartbeat
• Abnormal electrocardiogram up to cardiac arrest
• General weakness and lethargy
• Muscle weakness, inability to move
• Numbness, weakness, and heaviness in legs
• Confusion

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.

Inform your doctor if you notice pain, tenderness, or swelling from blood clots at the injection site.

Not known (frequency cannot be estimated from available data):

• Abnormally low blood sodium levels acquired in hospital (hyponatraemia).

Cerebral oedema due to abnormally low blood sodium levels (hyponatraemic encephalopathy). This may cause irreversible brain damage and death. Symptoms include: headache, nausea, vomiting, seizures, tiredness, and lack of energy.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, even if it is an adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaRAM.es

By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Potassium B. Braun 0.02 mEq/mL, Prediluted in 5% Glucose

Before opening: Do not store above 25°C.

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the label and on the outer packaging after EXP. The expiry date is the last day of the month indicated.

Do not use this medicine if the solution is cloudy or discolored, if you see particles in the solution, or if the container or closure is damaged.

This container is for single use only. After use, dispose of the container and any remaining contents.

6. Package contents and other information

Composition of Potassium B. Braun 0.02 mEq/ml Prediluted in 5% Glucose

• The active substances are potassium chloride and glucose.

1 ml of infusion solution contains 1.5 mg of potassium chloride and 50 mg of glucose (55 mg as glucose monohydrate).

1 L of infusion solution contains 20 mmol of potassium and 20 mmol of chloride.

The other component is water for injections.

Approximate caloric value: 835 kJ/l – 200 kcal/l

Theoretical osmolarity (approx.): 318 mOsm/l

Approximate pH: 3.5 – 6.5

Appearance of the product and contents of the container

Potassium B. Braun 0.02 mEq/ml Prediluted in 5% Glucose infusion solution is a transparent, aqueous, colourless to slightly straw-coloured solution of potassium chloride and glucose in water.

It is available in plastic (polyethylene) bottles containing 500 ml or 1,000 ml each, supplied in packs of 10 x 500 ml and 10 x 1,000 ml.

Only certain pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

• Braun Melsungen AG
  Carl-Braun Strasse 1
  34212 Melsungen
  Germany

Manufacturer

• Braun Melsungen AG
  Carl-Braun-Strasse 1
  34212 Melsungen
  Germany
  Tel: +49-5661-71-0
  Fax: +49-5661-4567

• Braun Medical S.A.
  Carretera de Terrassa 121
  08191 Rubí, Barcelona
  Spain
  Tel: +34-93-5866200
  Fax: +34-93-5881096

This medicinal product is authorised in EEA Member States under the following names:

Czech Republic: Kaliumchlorid/glucose 0,15% + 5% B. Braun
Estonia: Kalii chloridum/Glucosum B. Braun 1,5 mg/ml + 50 mg/ml, infuusioneste, liuos / infusionsvätska, lösning / infusioonilahus
Spain: Potasio B. Braun 0,02 mEq/ml Prediluido en Glucosa 5%
Finland: Kalii chloridum/Glucosum B. Braun 1,5 mg/ml + 50 mg/ml infuusioneste, liuos / infusionsvätska, lösning / infusioonilahus
Ireland: Potassium Chloride 0.15% w/v and Glucose 5% w/v solution for infusion
The Netherlands: Kaliumchloride 0,15% - Glucose 5%, oplossing voor intraveneuze infusie
Poland: Potassium Chloride 0,15% + Glucose 5% B. Braun
Portugal: Cloreto de Potássio 0.15% + Glucose 5% B. Braun
Slovakia: Kaliumchlorid/glucose 0,15%+ 5% B. Braun
United Kingdom: Potassium Chloride 0.15% w/v and Glucose 5% w/v solution for infusion

Date of latest review of this leaflet: May 2025

Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/)

This information is intended for healthcare professionals only:

Dosage

Adults:

The following recommendations are general guidelines for potassium.

Potassium

The amount required to correct moderate potassium deficiency and for maintenance can be calculated using the following formula:

mmol K+ required = (body weight [kg] × 0.2)* × 2 × (target serum K+** – current serum K+ [mmol/l])

*The term represents the extracellular fluid volume
** should be 4.5 mmol/l

The recommended maximum dose of potassium is 2 to 3 mmol per kg of body weight per 24 hours.

Maximum infusion rate

Up to 5 ml/kg body weight per hour, corresponding to 0.25 g glucose/kg body weight per hour.

Paediatric population:

Generally, a potassium replacement rate exceeding 0.5 mmol/kg body weight per hour should not be exceeded.

Maximum daily dose

The recommended maximum daily dose of potassium is 3 mmol/kg body weight in 24 hours. Under no circumstances should the maximum daily fluid intake dose be exceeded.

Method of administration

As a general rule, infusion pumps should be used for potassium infusion to ensure correct therapy delivery.

Special warnings and precautions

Solutions with low electrolyte content, especially sodium, should also be administered with caution in patients with hyponatraemia.

Care must be taken to avoid a marked decrease in plasma sodium levels, as this may be associated with the risk of osmotic central nervous system injury.

Monitoring of fluid balance, serum glucose, and other electrolytes may be necessary before and during administration, particularly in patients with non-osmotic release of vasopressin (syndrome of inappropriate antidiuretic hormone secretion, SIADH) and in patients receiving concomitant treatment with vasopressin agonist drugs due to the risk of hyponatraemia.

Serum sodium monitoring is particularly important for physiologically hypotonic fluids. The infusion solution of Potassium B. Braun 0.02 mEq/ml Prediluted in 5% Glucose may become hypotonic after administration due to glucose and its metabolism in the body (see Summary of Product Characteristics, sections 4.4, 4.5 and 4.8).

Paediatric population

Infusion of hypotonic fluids together with non-osmotic secretion of antidiuretic hormone (due to pain, anxiety, post-operative state, nausea, vomiting, fever, sepsis, reduced circulating volume, respiratory disorders, CNS infections, and metabolic and endocrine disorders) may trigger hyponatraemia.

Treatment of overdose

Immediate discontinuation of the infusion, electrocardiographic monitoring, and if necessary, increasing urine flow and thus excretion of fluids and electrolytes. Administration of sodium bicarbonate and insulin. If insulin is administered to enhance cellular uptake of potassium, glucose should also be administered to prevent hypoglycaemia. In patients with persistent ECG abnormalities, calcium gluconate may be administered, for example, to counteract the cardiotoxic effects of potassium. Haemodialysis or peritoneal dialysis may be required in patients with renal failure.

Incompatibilities

This medicinal product must not be mixed with other medicinal products unless compatibility has been previously demonstrated.

Shelf-life after first opening of the container

From a microbiological standpoint, the product should be used immediately. If not used immediately, the user is responsible for the storage conditions and duration prior to use, which normally should not exceed 24 hours at 2 to 8 °C, unless dilution has taken place under controlled and validated aseptic conditions.

For complete information on this medicinal product, see the Summary of Product Characteristics.